AI-Assisted Relaxation and Breathing Training in Postmenopausal Women

Condition(s) studied

Investigational drug(s) / intervention(s)

Physiotherapist-Guided Relaxation and Breathing Training: Participants will perform the sessions individually and face-to-face under the supervision of a physiotherapist. Relaxation positions and breathing exercises will be guided and monitored by the physiotherapist. The training will be conducted three days a week for eight weeks, with each session lasting approximately 30 minutes.

Artificial Intelligence-Assisted Relaxation and Breathing Training: In this group, a 30-minute relaxation and breathing training script will be created by the researchers based on instructional prompts provided to the artificial intelligence system. The generated script will be reviewed and finalized by the researchers and then converted into an audio file using an AI-based voice generation program. Participants will listen to these audio recordings asynchronously via smartphone or tablet, three days a week for eight weeks, with each session lasting approximately 30 minutes. They will also be asked to keep a daily practice log.

Control Group - No Structured Training Program: Participants will be informed about relaxation and breathing exercises. After the initial assessments, they will be asked to continue their daily routines and not to participate in any structured exercise training program for eight weeks. After the intervention period, participants in the control group will be invited to join one of the training groups if they wish.

Study summary

This study aims to evaluate the effectiveness of relaxation and breathing training delivered by a physiotherapist and by an artificial intelligence-assisted system in postmenopausal women with non-specific chronic musculoskeletal pain. Menopause and the postmenopausal period are associated with decreased estrogen levels, structural and functional changes in the musculoskeletal system, increased pain prevalence, reduced muscle function, and impaired quality of life. Relaxation techniques, breathing-focused exercises, and mind-body practices have been shown to reduce pain, improve psychological well-being, and enhance sleep quality. With the growing use of digital health technologies, AI-supported relaxation training may offer personalized guidance, easy accessibility, and sustainable home-based practice, although its effectiveness in postmenopausal women has not yet been demonstrated.

In this three-arm randomized controlled trial, participants will be assigned to physiotherapist-led relaxation and breathing training, AI-assisted relaxation and breathing training, or a control group. Interventions will last eight weeks and include sessions three days per week, each approximately 30 minutes. The physiotherapist-guided group will perform sessions face-to-face, while the AI-assisted group will complete prerecorded relaxation and breathing exercises created with AI-generated scripts and voice recordings. The control group will continue daily routines without structured training during the study period.

Assessments will be conducted at baseline and at the end of eight weeks. Outcome measures will include pain severity, pressure pain threshold, musculoskeletal symptoms, menopause-specific quality of life, psychological status, sleep quality, dyspnea, and participant satisfaction. The study aims to compare the effects of physiotherapist-led and AI-assisted training modalities on pain, musculoskeletal health, sleep, psychological well-being, and quality of life. Findings are expected to contribute to the development of accessible and cost-effective interventions that support symptom management and improve the daily functioning of postmenopausal women.

Eligibility

Primary outcome measure(s)

• Pain Intensity — Baseline and Week 8
  Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain on a 10 cm horizontal line ranging from 0 ("no pain") to 10 ("unbearable pain").
• Pressure Pain Threshold — Baseline and Week 8
  Pressure pain threshold will be measured using a digital algometer. Participants will indicate when they first perceive pain. Three measurements will be taken from each site, and the mean value will be used for analysis. All measurements will be completed by the same trained researcher.
• Menopause-Specific Quality of Life — Baseline and Week 8
  The Menopause-Specific Quality of Life Questionnaire will be used to evaluate the impact of menopausal symptoms on quality of life. The scale consists of 32 items and four domains: vasomotor, psychosocial, physical, and sexual. The minimum possible score is 1, and the maximum possible score is 8, with higher scores indicating worse outcomes. An increase in the total score reflects greater symptom severity and a decrease in quality of life.

Trial sites (1)

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